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临床试验/NCT03049033
NCT03049033招募中不适用

Neurologic Music Therapy for Enhancing Fine Motor Control in Parkinson's Disease

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Quality of Life (QOL) Outcome: QOL 1 (change in the 39-Item Parkinson's Disease)

研究概览

简要总结

Parkinson's Disease (PD) is defined by characteristic motor symptoms including slow movements, small movements, difficulty with movement initiation and disruptions in timing. Besides gross motor symptoms, fine motor impairments in PD cause difficulties with everyday tasks such as writing, self-care, and fine object manipulation. These activity limitations can lead to disability, social isolation, and a reduced quality of life. In a series of breakthrough studies Michael Thaut and colleagues developed Neurologic Music Therapy (NMT) and found it can address many gross motor impairments and improve gait and balance. Other music therapies such as Music-supported Therapy (MST) have proven motor benefits in stroke patients through movement exercises with musical instruments. However, the pathological basal ganglia (BG) in PD brains leads to a reduced supply of those internally generated movements. In contrast, externally cued movements (eg. via a beat or a rhythm) during NMT sessions are instantaneously entrained to the period of a rhythmic stimulus possibly without involvement of the BG. The underlying idea is that rhythm is the essential component relating music specifically to motor behavior. The mechanism of action is called "rhythmic entrainment" where one system's motion or signal frequency entrains the frequency of another system. The effect of NMT on fine motor function has not been investigated yet. Music activities are important in the lives of many older adults. Notably, the use of music has been associated with increased well-being for older adults, as it fosters social connection and mood regulation. Furthermore, many musical activities have limited physical demands, making them attainable for individuals who are living with mobility impairments or other physical restrictions. Based on the literature and the investigators preliminary studies, the investigators propose to test the efficacy of Neurologic Music Therapy in comparison to Music Supported Therapy and Occupational Therapy (OT) as standard of care on adults in the Parkinson's spectrum. The investigators have defined a working plan using different musical instruments and growing tempo to specifically improve fine motor movements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45 to 85
  • Diagnosis of Parkinson's Disease using the UK Brain Bank Criteria
  • Fine motor impairments (if available, scores 2 and higher on the UPDRS motor examination part III.23 and 24)
  • Medication stable for at least 30 days.

排除标准

  • Features suggestive of other causes of parkinsonism, including cerebrovascular disease or history of major head trauma
  • Inability to move fingers or hands
  • Hoehn and Yahr stage 4 and higher
  • Ferrous metal implants which may interfere with the MEG data acquisition and/or be an MRI safety concern
  • Participants engaged in other research studies involving music therapies
  • Participants whose insurance does not cover Occupational Therapy costs or who have no insurance.

结局指标

主要结局

Quality of Life (QOL) Outcome: QOL 1 (change in the 39-Item Parkinson's Disease)

时间窗: Baseline and 5 weeks

First QOL outcome will be a change in the 39-Item Parkinson's Disease Questionnaire.

Mechanistic Outcome: Neurophysiology 2 (change in auditory-motor functional connectivity using Magnetoencephalography)

时间窗: Baseline and 5 weeks

Our second neurophysiology outcome will be a change in auditory-motor functional connectivity using Magnetoencephalography

Clinical Outcome: Motor 1 (change in the Grooved Pegboard Test)

时间窗: Baseline and 5 weeks

First motor outcome will be a change in the Grooved Pegboard Test.

Mechanistic Outcome: Neurophysiology 1 (change in motor beta and gamma power using Magnetoencephalography)

时间窗: Baseline and 5 weeks

Our first mechanistic outcome will be a change in cortical motor beta and gamma power using Magnetoencephalography.

次要结局

  • Clinical Outcome: Motor 2 (change in the Unified Parkinson Disease Rating Scale Part III)(Baseline and 5 weeks)
  • Quality of Life (QOL) Outcome: QOL 3 (change in the Hospital Anxiety and Depression Scale)(Baseline and 5 weeks)
  • Clinical Outcome: Motor 3 (change in the Finger-Thumb opposition from the Neurological Evaluation Scale)(Baseline and 5 weeks)
  • Quality of Life (QOL) Outcome: QOL 2 (change in the Clinical Global Impression - Improvement Scale)(Baseline and 5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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